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Use of Insulin Adjustment Device DreaMed Advisor Pro During Routine Clinical Use for Subjects With Diabetes Type 1

NCT04271228 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-03-26

No results posted yet for this study

Summary

The DreaMed Advisor Pro, is a software which automatically analyses treatment information, learns patient's needs and accordingly suggests adjustments in insulin dosing (FDA approved decision support system). The Advisor Pro uses information gathered from glucose monitoring (sensor readings or capillary blood glucose measurements), insulin dosing and meal data during daily routine home care. Following a 5 minute data collection and analysis, the algorithm learns and suggests pump-setting changes for optimization of glucose control. The algorithm is designed as an advisory tool for health care professionals and has three main components: First, data analysis report - a statistical analysis of the insulin pump and sensor data: insulin delivery, bolus-calculator rate of use, sensor glucose variables, hypoglycemic and hyperglycemic patterns. Second, recommendations, alert messages based on aforementioned data for example "pay attention- you skipped boluses", basal/bolus ratio is too high, bolus delivery compliance, glucose target recommendations and more. Third, a recommendation for new insulin pump settings: including basal intervals and rate, different carbohydrate ratio according to time of day, correction factor and insulin sensitivity time. The Advisor Pro can be used to optimize insulin pump setting during clinical visits, in-between visits or as part of virtual (telemedicine) visit. The objective of the proposed study is to evaluate the use of Advisor Pro by Health Care Providers for regular clinical visits and in between visits titration for adjustment of insulin pump settings. The study design is an open label, prospective, observational study that will include up to 100 participants with Type 1 Diabetes using insulin pumps and monitoring glucose levels by continuous glucose monitoring including flash glucose monitoring.

Conditions

Interventions

DEVICE

DreaMed Advisor Pro

Using the DreaMed Advisor Pro as an advisory tool for Health Care Professionals during routine clinical use

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Revital Nimri, MD · Schneider Children;s Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-15
Primary Completion
2022-01-19
Completion
2022-01-19

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04271228 on ClinicalTrials.gov